Vaccination as an Equaliser? Evaluating COVID-19 Vaccine Prioritisation and Compensation

Abstract This article assesses the equity of COVID-19 vaccination programmes in three jurisdictions that have historically taken different approaches to the institutionalisation of equity considerations. The Sars-Cov-2 pandemic has thrown into sharp relief persistent societal inequalities and has added novel dimensions to these problems. Certain groups have proved particularly vulnerable, both in terms of infection risk and severity as well as the accompanying social fallout. Against this background the implementation of ‘objective’ vaccination programmes may seem like a great leveller, addressing the disparate risks that are tied to social determinants of health and the pandemic behemoth. However, implementing vaccination programmes in an equitable manner is itself essential for the realisation of such a vision. This article undertakes a comparative analysis of the English, Italian, and American jurisdictions and critically assesses two aspects of their vaccination frameworks: (i) the prioritisation of groups for vaccination and (ii) the nature of public compensation schemes for those who have suffered vaccine-related injuries. It examines whether and to what extent these measures address the inequalities raised by COVID-19 and the role of the law in this pursuit.


I. INTRODUCTION
The Marmot Review posited that 'health inequalities that could be avoided by reasonable means are unfair'. 1 COVID-19 provided responders the opportunity to address the disease's well-documented disproportionate impact on societies' most vulnerable. This applied especially to the deployment of vaccines which formed a significant aspect of the public health response to the pandemic. Though states can pursue many avenues to address COVID-induced health inequalities, national vaccination programmes serve as one of the most farreaching and widely-adopted population health interventions available, and as such beg further examination.
This contribution argues that the implementation of these programmes and their congruence with the ideal of health equity was closely related to the legal frameworks in which they were embedded. Two specific dimensions of the COVID-19 vaccination process were selected for comparison, given the opportunities each present to infuse equity considerations in their design and implementation. First, vaccine prioritisation schemes could consider equity in allocation strategies adopted in times of vaccine scarcity. Second, vaccine injury compensation schemes redistribute resources to the subset of the population suffering from vaccine injury-induced disability. Incorporating COVID-19 into these schemes can address lack of confidence or access difficulties exacerbated by social disadvantage while simultaneously classifying the injured into a distinct category of vulnerability.
To test this hypothesis, this article examines three legal systems-England, Italy, and the USA-that embrace vaccination as a population health strategy, but have pursued different strategies to institutionalise equity considerations. It is argued that this variation shapes COVID-19 vaccination regulation and in turn demonstrates the advantages and disadvantages of the respective approaches. England has primarily adopted a procedural approach, whereby legal norms direct the attention of decisionmakers to relevant equity considerations, but grants them discretion to determine the outcome of these deliberations. This is paired with a relatively limited system of substantive rights. Italy embraces a comprehensive substantive approach whereby the principle of equity goes hand in hand with that of social solidarity. Under Article 3 of the Constitution, all citizens are considered formally equal before the law and the state must give those who are disadvantaged the means to participate equally in social and political life. In contrast, the USA features an inherently 'political' approach, where the fifty federal states individually confront a socio-political ideal of equity without guidance from codified mandates.
These differentiated systems lend themselves to a comparative analysis, assessing how the different normative approaches shaped: (i) vaccine prioritisation programmes' recognition of the greater need of some groups for the vaccine, as well as the need to overcome pre-existing patterns of disadvantage, and (ii) the realisation of contrasts with these (formally) universal approaches. Its minimalistic welfare state presents a history of restricted healthcare access and social injustice. The racial and ethnic disparities among COVID-19 cases, hospitalizations, and deaths can be traced to established intersectional dimensions of the social determinants of health. 11 There are nevertheless common challenges across these states, with COVID-19 circumscribing the opportunities of historically disadvantaged populations to achieve health and well-being. Disparate COVID-related health outcomes corresponded with the following characteristics: (i) increased age; 12 (ii) health conditions, including physical and learning disabilities; 13 (iii) race/ethnicity; 14 (iv) socio-economic disadvantage; 15 and (v) membership among socially excluded groups, including prisoners, 16 undocumented migrants/asylum seekers 17 and the homeless. 18 These give rise to an inequality in need that ought to be factored into equity-oriented health measures. As disparities based on these characteristics provide an added impetus for equitable responses, they form the principal focus of this article.

B.The Role of Vaccination as Equaliser
Considering the above equity considerations and in response to these dangers, vaccination can act as an equalising agent. While no panacea, vaccination offers one of many avenues through which the state can address unequal distribution of societal resources and risk. Vaccination represents a scientifically-backed means for the state to minimise shared risks, and to protect and promote health through minimally invasive means. 19 Vaccinations address health threats among the immunologically and socially vulnerable, by providing both individual and community-level protections. Finally, key vaccination services are also ordinarily made available through the welfare state at no or reduced cost in our three jurisdictions.
A comprehensive vaccination scheme involves a combination of interrelated elements, including measures that: ensure the availability of vaccines, enable universal access, promote vaccine uptake, and provide injury compensation. Equitable vaccination schemes can and should be designed to address potential inequalities within each of these dimensions. This article examines two key state-influenced elements of vaccination programmes to assess the factors that affected the realisation of this objective in our jurisdictions.

III. COMPARING EQUITY CONSIDERATIONS IN ENGLAND, ITALY, AND THE UNITED STATES' VACCINATION SCHEMES
A. Vaccination Prioritisation Initial COVID-19 vaccine scarcity presented nations with the difficult task of apportioning available doses. This often took the form of phased distribution, establishing prioritisation groups based upon defined characteristics of particular populations. This section examines how these schemes responded to equity considerations and how the characteristics of the respective legal systems shaped the process.

England
In England, the Department for Health and Social Care (DHSC) delegates its responsibilities for delivering immunisation to NHS England, while maintaining strategic oversight. 20 In this task it is aided by the Joint Committee on Vaccination and Immunisation (JCVI), an independent departmental expert committee with a basis in statute. 21 The advice of this committee has become binding in some restricted instances, though the relevant conditions were not fulfilled for COVID-19. 22 Consequently, the legal basis for prioritisation was the DHSC's translation into policy of JCVI recommendations, in the course of which it performed its own equality impact assessment. 23 Under this policy, the first priority group was those aged 80 years and over, older care home residents and those employed in the health and social care sector. 24 Following this there was a stratification according to age and clinical vulnerability, with the clinically extremely vulnerable being equated with those aged 70-74 years and those at risk being prioritised after those aged 65-69 years. 25 The overriding goal of this approach was to reduce harm and to ensure easy and quick deliverability, given that age and co-morbidities were taken as the strongest indicators of a heightened absolute risk. 26 The vaccination of those occupied in the health and social care sectors was intended to provide a further benefit to these groups and an added society-wide benefit of maintaining well-functioning health and social care systems.
For those populations where evidence indicated that COVID-19's impact was worsened by health inequalities, the increase in risk was said to be uncertain, subject to confounding variables and, in any case, smaller. 27 The impetus to address these factors was thus reduced. The response to these wider health inequalities was also in conflict with the goal of designing a simple and speedily deliverable programme. Separating between sub-groups was argued to decrease the public understanding of the system and the trust in it. 28 Singling out other groups for prioritisation was feared to reinforce negative stereotypes and to decrease their trust in vaccination, as it may be perceived as 'experimental'. 29 Further, dimensions such as membership of protected groups, ethnicity, or refugee status were poorly tracked. 30 This complicated a response to health inequalities through vaccination and meant that these populations were not initially included in the national prioritisation programme. Instead, local decision-makers were given some operational flexibility to mitigate health inequalities in their areas. 31 Egalitarian considerations were only realised in the design of the vaccination programme in so far as they were aligned with the above harm-reduction framework, i.e. concerning age and comorbidities. To the extent that the mitigation of inequalities was raised as a separate 'principle', it was only retrospectively addressed by two policy changes. The first change related to the prioritisation of those with learning disabilities. Only those with Down's syndrome, those with 'severe and profound' learning disabilities and those in residential care had been prioritised at the national level. This created a distinction between those with mild/moderate and those with severe learning disabilities which was not readily captured in clinical records. 32  authorities to make use of their local flexibility to treat all persons on the learning disability register as 'at risk'. 33 A change in national approach followed in late February that placed all individuals with learning difficulties in the 'at risk' category. 34 A second change concerned the homeless. 35 Again, a national approach to prioritisation had not been envisioned. Nevertheless, homeless populations faced substantial risks of infection and poor health outcomes, given related comorbidities. Moreover, many such co-morbidities were undiagnosed and could not be relied on as proxies for prioritisation. 36 In response, local decision-makers again took the lead in prioritising these populations. 37 Subsequently, following JCVI advice, the DHSC changed its policy in March. The homeless were included in the 'at risk' cohort. 38 Despite such positive changes, other vulnerable groups were not prioritised in England, including: prisoners, asylum seekers, ethnic minorities, and the socio-economically disadvantaged.
The law's role in the realisation of these equity-related objectives has been notable. Particularly that of the obligation on public actors to consider equality implications under the general Public Sector Equality Duty (PSED) contained in the Equality Act (EA) 2010. 39 That this duty applies to the Secretary of State and the DHSC is placed beyond doubt by their specification in the EA. 40 The JCVI, in contrast, is unlisted and subject to the duty only when performing a public function. 41 In 2018 it had denied this regarding the provision of vaccination recommendations. 42 However, this was challenged under the PSED, 43 and the JCVI conceded the point in its COVID-19 vaccination advice, recognising its 'legal duty to prevent discrimination based on protected characteristics'. 44 Given the public interest in the prioritisation scheme for the COVID-19 vaccine, and the closeness with which the Committee worked with the DHSC in delivering the government's policy objectives, this is undoubtedly the correct conclusion. 45 Consequently, the PSED required the Secretary of State and the JCVI: to 'have due regard to the need to [. . .] advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it'. 46 Such regard must be given before the decision. 47 The relevant, currently covered protected characteristics are age, sex, disability, and race. 48 It is clear that an authority may have to consider affording preferential treatment to one of these protected groups, if its needs are different. 49 Thus, insofar as the old and disabled, who had a heightened need, were given preferential access to the vaccine, this was supported by the legal framework. Insofar as the disparate needs of other protected groups were unmet, it is to be noted that the PSED leaves considerable discretion to decision-makers: The concept of 'due regard' requires the court to ensure that there has been a proper and conscientious focus on the statutory criteria, but if that is done, the court cannot interfere with the decision simply because it would have given greater weight to the equality implications of the decision than did the decision maker. 50 Although this duty may be further heightened where a large vulnerable population is affected, 51 the JCVI's detailed and responsive elaboration of equity considerations arguably falls within this discretion. By comparison, the Secretary of State did not appear to have paid them any regard. Only after the initiation of legal proceedings-concerning the decision not to prioritise all those with learning disabilities-was an impact assessment produced. Ultimately this satisfied the High Court that the relevant considerations had been present, and led to a refusal of permission for judicial review. 52 This indicates that, for this highly sensitive political decision, the PSED did direct decision-makers to important health equity considerations, although it does not provide a tool for stricter legal oversight.

Italy
Italy has a prominent legal and political culture concerning the universal provision of vaccination, extending to the constitutional permissibility of population-wide vaccine 44  mandates. 53 Due to COVID-19 vaccine scarcity, the initial approach was not to use this power, 54 but to pursue a staggered vaccination campaign that would ultimately guarantee free population-wide access. This campaign was organised according to the prioritisation criteria presented to Parliament by the Minister of Health in December 2020, 55 and then adopted via Ministerial Decree in January 2021. The strategic plan was developed by an interdisciplinary working group set up at the Ministry of Health, together with the Special Commissioner for the COVID-19 emergency, The Italian National Institute of Health, the Italian National Agency for Regional Healthcare Services and the Italian Medicines Agency. 56 The working group consulted with the National Bioethics Committee. The plan was explicitly based on core constitutional values and especially on the right to health of the individual and the community. When submitting it to Parliament, the Minister announced that 'no inequalities will be allowed in the vaccination campaign'. 57 As an initial phase, the plan provided for the prioritisation of healthcare professionals as well as staff and residents of residential care facilities and all elderly over 80. 58 A second stage of the campaign, implemented in February 2021, envisaged a prioritisation based on health conditions. Clinical vulnerability to COVID-19 was primarily identified with advanced age, but also with the co-morbidities contained in the vaccination plan-including Down's syndrome and enumerated severe physical or mental disabilities. 59 Simultaneously, the plan provided for a 'parallel track' of vaccinations exclusively using vector vaccines, 60 which were then only recommended for people under 55. This permitted vaccination based less on clinical conditions than certain social considerations. In particular, it was envisaged that educational staff, the armed forces and the police, prison staff and inmates, and staff working in civil and religious communities or carrying out 'other essential activities' could be vaccinated. 61 The plan's implementation was entrusted to the health administrations of the individual regions. Parallel prioritisation criteria sought to address some of the aforementioned inequalities. Above all, the inclusion of prison staff and inmates improved the vulnerable conditions of the prison population during the pandemic. 62 In addition, the prioritisation of educational staff prompted the resumption of school activities, mitigating the problems posed by the so-called 'digital divide'. 63 However, this implementation brought into focus other inequalities. Vaccinating the young and less clinically vulnerable before some of the elderly generated feelings of inequality and injustice. 64 Moreover, the vague reference to 'other essential activities' posed interpretation problems that exacerbated certain inequalities. Some regions prioritised socioeconomically advantaged groups, including judges, lawyers, and journalists, thus creating forms of discrimination that the National Committee for Bioethics has described as 'ethically relevant'. 65 As a result of these challenges, a further update of the vaccination plan in March resolved the ambiguity around 'other essential activities'. The update removed the distinction between vector and RNA vaccines and considered that all people with severe disabilities, as defined by Law no. 104/1992, were vulnerable. 66 As a state action, the vaccine plan must be constitutionally compatible. The need to protect the functioning of the national healthcare system-and thus the right to health as a public interest (Article 32)-justified the prioritisation of medical personnel. In relation to equity, Article 3(2) mandates that state measures must guarantee substantive equality in circumstances of unequal starting conditions. The prioritisation of more vulnerable individuals-those of advanced age or those with comorbidities-was no doubt an adequate instrument to achieve this equity goal. 67 Similarly, prioritising individuals belonging to areas particularly affected by the pandemic, such as education and prisons, contributed to achieving substantive equality under Article 3. The category of persons performing 'other essential activities' did not contribute to the goal of restoring equality because of its vagueness, which left room for divergent interpretations. It was a missed opportunity to effectively protect other factually disadvantaged groups. Additional prioritisation for other vulnerable groups such as ethnic minorities, asylum seekers or the homeless could have been constitutionally permissible.

United States
COVID-19 vaccination prioritisation in the USA is marked by a significant lack of codified law with which to guide it. Despite this, vaccination efforts attempted to at least consider health inequalities, even if the ultimate result is insufficient. In the USA, a federal republic in which many public health powers belong to states unless federally pre-empted, each state maintains responsibility for developing its own COVID-19 vaccination distribution plan. 68 Through unique mechanisms, such as state agency task forces or advisory panels, these jurisdictions determined COVID-19 vaccine allocation strategies, often based on non-binding guidelines issued by the federal government or national entities. Two key guideline-issuing entities are the National Academies of Sciences, Engineering, and Medicine (NASEM) and the Advisory Committee on Immunization Practices (ACIP).
Both NASEM and ACIP considered equity in their suggested initial vaccine prioritisation strategies, and emphasised avoiding disparity exacerbation or creation, though each suggested different methods of doing so. 69 In its Framework for Equitable Allocation of COVID-19 Vaccine, NASEM explicitly acknowledges that vaccine allocation schemes should address COVID-related inequities 'rooted in structural inequalities, racism, and residential segregation' as a moral imperative. 70 ACIP, upon whom CDC relies to make immunisation recommendations, similarly set forth goals of disparity reduction in light of COVID-19 inequity data. 71 While plans suggested ways to incorporate equity considerations into scarce vaccine distribution, they remained non-legally binding suggestions. Though many states mirrored ACIP recommendations, fidelity to NASEM and ACIP guidelines was not absolute. After guidance issuance, vaccine prioritisation fell victim to the classic federal public health response challenge in the USA-heterogeneity. 72 Deviation from the guidelines among states was especially pronounced when it came to equity considerations. Almost every state included frontline healthcare and long-term care workers as first priority populations, largely in accord with ACIP recommendations. 73 ACIP next prioritised essential workers, ranking this population partly based on the reported high incidence among members and 'the disproportionate impact of COVID-19 on workers who belong to racial and ethnic minority groups'. 74 ACIP names justice and health inequity mitigation among the ethical principles that support this prioritisation, acknowledging essential workers' risk of exposure and that vaccination 'minimis[es] societal disruption and prevent[s] morbidity and mortality'. 75 However, not all states prioritised essential workers next, some opting to prioritise teachers, those with elevated health risks, or the elderly after healthcare workers. 76 While long-term care facility staff, who may come into contact with people with disabilities, were initially first prioritised, those living with disabilities themselves were variably prioritised. 77 States that prioritised disabled populations did so according to ranging definitions of the term, at times including those living with intellectual and developmental disabilities, physical disabilities, mental or behavioural health conditions, or some combination of these categories in the definition. 78 Incarcerated and homeless populations were similarly nonuniformly prioritised among states. 79 By using disadvantage indices, some states accounted for potential socially derived vulnerabilities in their COVID-19 vaccination plans. Disadvantage indices are statistical measures that seek to capture the relative average disadvantage of a population living in a particular geographic area. Relevant metrics include income, education level, and housing quality. 80 These indices, such as the Social Vulnerability Index (SVI), Area Deprivation Index (ADI), and COVID-19 Community Vulnerability Index (CCVI), can all help address inequality in COVID contexts, capturing populations to which immunity is most required, in light of the ability to social distance or monitoring areas experiencing disparate impacts. 81 A survey of state vaccination plans shows that thirty-seven jurisdictions committed to using some type of disadvantage index. 82 Twenty-nine jurisdictions refer to SVI in their prioritisation plans, while the thirteen remaining utilise other indices. 83 NASEM recognised vulnerability indices as valuable means to accomplish equity objectives in a conscious, evidence-based way.
An index tool that can account for racial/ethnic inequity better accords with the jurisdiction's existing constitutional precedents. States could face significant constitutional challenges if they used individuals' race or ethnicity as primary factors in 75  prioritisation decisions. 84 While no precedent for allocating scarce health resources based on race exists, race-based classification has been reviewed in the context of other public goods under strict scrutiny. 85 This requires that governmental measures be narrowly tailored to achieve a compelling interest. Considering other Supreme Court precedents, using only race/ethnicity as the sole determining allocation factor will likely fail a strict scrutiny test. 86 However, incorporating race/ethnicity as one of numerous data points in a community-level index is likely to face a lower level of scrutiny and would consequently prove less challenging. 87 Still, without a positive, unifying legal framework each state acted independently in their approach to vaccine allocation. Even states that chose to utilise vulnerability indices did not always employ the same index, nor did they employ indices to the same ends. Some states employed disadvantage indices to apportion vaccines or vaccination appointments. Other states committed to reserving percentages of vaccine allocations to areas with high disadvantage scores, specifically referring to SVI or CCVI. 88 Still others weighted allocations using SVI metrics to increase allocations to disadvantaged populations. 89 Despite stated equity commitments and planning considerations, inequalities persisted, with data revealing lower vaccination rates in non-White communities. 90 While epidemiological factors played a predominant role in US states' prioritisations, some social aspects also mattered. Prominent guidance mentioned equity considerations, though a lack of binding legal obligation allowed for divergence and discrepancy.

B. Vaccination Injury Compensation Schemes
England, the USA, and Italy feature public no-fault payment mechanisms for those injured by vaccines. These too can be analysed in terms of the outlined equity objectives. Most directly these schemes constitute a state's response to disparate needs that have arisen from a public health measure benefitting society as a whole. Addressing vaccine injury-induced disability responds to the fact that the inevitable 'burden of injury itself is unequally distributed' among the population. 91 Another objective that policymakers pursue through these mechanisms is to increase vaccine confidence. Under this approach, the position of vaccinehesitant populations should grant additional significance to the task of designing 'trustworthy' schemes. Reassuring these groups through a remedy in case of injury could encourage equitable utilisation.

England
Following the Report of the Royal Commission on Civil Liability and Compensation for Personal Injury (the Pearson Report), the Vaccine Damage Act (VDPA) 1979 was enacted to create the first public scheme of payments for vaccine damage in England: The Vaccine Damage Payment Scheme (VDPS). 92 Although this has evolved it remains in force today. For present purposes, a significant change has been the addition of COVID-19 to the list of specified diseases to which the act applies. 93 Additionally, for COVID-19 vaccines there was an abrogation of the condition that the person receiving the vaccine must (generally) be under 18. 94 The exhaustive listing of such diseases, the absence of wider legal criteria for their identification, 95 and the discretionary relaxation of certain requirements, exemplify the essentially political basis for the scheme. 96 Access to the scheme is relatively uncomplicated, with the submission of a form to the relevant agency. 97 Beyond this, the VDPA imposes two principal limitations on claims. First, it only provides remedies to those who suffer death or severe disablement from vaccination. 98 'Severe' encompasses 'disablement to the extent of 60 per cent'-assessed according to wider social security principles. 99 Second, the scheme requires proof of causation on a balance of probabilities. 100 This corresponds to ordinary civil law claims-which are not precluded 101 -but, unlike such claims, it does not require proof of fault. Upon a successful claim, the Secretary of State can award a statutory sum of up to £120,000 in a single payment. 102 No special provisions are made for the funding of this.
The VDPS was proposed as a political solution to the exigencies of a particular factual situation. It was a countermeasure to the waning trust in childhood vaccination programmes. 103 Hereby the particular vulnerability of children and the need to assist families became prominent considerations in the inception of the scheme. 104 A need to signal confidence in vaccination and to increase vaccine uptake was central to the VDPA's creation. 105 In discussing the impact on vaccination uptake, the Pearson Commission considered that 'the Government must be confident about vaccination before it would make such provision'. 106 An understanding of the Act as a political, fact-specific response is further supported by its characterisation as an 'immediate' or 'interim' measure by the Labour Government, which intended to follow up with a more comprehensive scheme. 107 However, this prospect was forestalled by the Labour Party's election loss in 1979.
Recognising the role of external circumstances is not to deny that socio-political ideals underpinned the VDPA. Through its implementation, Parliament recognised a distinct degree of responsibility for the vaccine injury based on: the public benefit derived from vaccinations; 108 the moral responsibility that stemmed from stateendorsed vaccination programmes, 109 and/or the desire to spread the cost of the resulting hardship across the community. 110 The pursuit of these goals helps to explain the outlined nature of the scheme, especially why its remedy is not compensatory in the sense of corresponding to the loss suffered. 111 The statutory sum is a limited recognition of the state's moral responsibility for the injury, intended only to alleviate distress and to provide a measure of assistance to the injured and their carers. Providing true compensation was explicitly left to the common law courts. 112 Consequently, the availability of independent civil law claims is central to the proper functioning of the scheme, though notably restricted in the context of COVID-19 vaccines. 113 In assessing the law's influence on this scheme one may ask whether the European Convention on Human Rights (ECHR) provides a legal framework for assessing the scope of the VDPS's coverage. Did it mandate that COVID-19 be added to the list of specified diseases? Could it be used to challenge persistent distinctions drawn by the VDPS, for instance between those who have similar needs but are deemed to be more/less than 60% disabled? 114 Two cases suggest that the ECHR is ill-suited to play this role. In Godfrey v United Kingdom 115 the VDPA was claimed to be in breach of Articles 8 and 14 by compensating only those suffering injuries after (but not before) 1948-i.e. by drawing an unjustified distinction between disabled individuals with comparable needs. This claim was declared inadmissible by reference to the Convention's limited scope relating to social security measures. Recently the Court of Appeal echoed this approach in R (on the application of CN) v Secretary of State for Health and Social Care. 116 While this did not concern the VDPA itself, it involved a 106  challenge to a similar compensation scheme that excluded the claimant's illness from a list of admissible conditions. 117 Given that the Secretary of State was 'concerned with both judgments of social and economic policy and with disability' the court accepted that they would be subject to a 'wide margin of appreciation' in justifying limitations on the scheme. 118 Although the issue of disability discrimination was thus recognised, the ECHR cannot meaningfully determine the scheme's coverage under the current deferential approach.
In contrast, the PSED under the EA proactively informed the extension of the VDPS to COVID-19. This sought to achieve equity and enhance public trust by putting COVID-19, with its greater impact on the oldest age groups, on equal footing with other vaccines. 119 Further, the immediate application to adults must also be seen in the context of a 2018 concession that the PSED had been breached by not taking this step for influenza vaccination. 120 This legal mechanism thus strengthened the English scheme's emphasis on encouraging vaccine uptake and it framed the decision to meet the needs of one especially vulnerable group.
Overall, the consideration of the PSED was, nonetheless, perfunctory. There was no mention of the benefit the VDPS could provide to other at-risk groups, including certain ethnicities, and those with pre-existing disabilities. Wider changes to the VDPS in light of COVID-19 were also curtly dismissed by reference to political and time constraints. 121 In this respect, this process contrasts unfavourably with the assessments of vaccination prioritisation. While a more comprehensive consideration may not be legally mandated (see section III.A.1.), closer regard to the legal framework could have directed decision-makers to a more consistent, equitable response.

Italy
The Italian no-fault compensation scheme is provided for by Law no. 210/1992. It was only explicitly extended to encompass COVID-19 vaccinations in late January 2022. Article 20(1) of Decree-law 27th January 2022, no. 4, provides that compensation shall be paid to 'those who have suffered injury or disability, which resulted in a permanent impairment of psycho-physical integrity, due to vaccination against SARS-CoV-2 recommended by the Italian Health Authority'. Article 20(1-bis) allocated e50 million to this scheme for the year 2022 and e100 million per year starting from 2023.
Regarding the access conditions and remedy, it must be noted that the scheme implements an 'equitable system of compensation' which does not aim to provide recompense for the damage suffered. 122 Such an award can still be pursued through civil law. 123 In comparison with such a claim, a victim only has to prove causality between the vaccine and the damage-and not fault. 124 The causality requirement is generally judicially interpreted as a criterion of 'reasonable scientific probability', whereby judges can base their decision on a preponderance of the evidence and the consideration that a causal link is 'more likely than not'. 125 However, some cases and commentators have indicated that the causation requirement is to be assessed less stringently in no-fault compensation cases than in civil liability cases. The mitigation of the burden of proof and a less stringent causation assessment allegedly arise from the social solidarity function of this instrument. 126 Albeit controversial, this approach is part of a wider judicial trend. 127 Upon a successful claim, Law no. 210/1992 grants a lifelong measure of support, 128 the amount of which is established by reference to eight categories of compensation that correspond to the severity of the injury. 129 For 2021, the monthly sum ranges from e803,68 to e899,98. 130 Moreover, Law no. 229/2005 grants an additional monthly living allowance to be split between the injured subject and related carers. Depending on the category of damage, this is four to six times the amount granted by Law no. 210/1992.
The nature of this remedy accommodates the demands of the Constitutional Court, which repeatedly stated that the sum cannot be purely trivial 131 and shall consist of an 'equitable' compensation. Its precise amount is nonetheless subject to statutory determination 132 and its constitutional legitimacy could only be doubted in the extreme case of the compensation being so negligible as to de facto nullify the right itself. 133 The extension of the compensation scheme laid down in Law no. 210/1992 to include COVID-19 vaccines was not a pure act of political will. While the government may have eventually decided to take action, it was also obliged to do so by substantive principles of the constitutional order, as elaborated by the Constitutional Court. Had the government further delayed in enacting such regulation, the same outcome would have eventually been brought about by the Constitutional Court itself. A survey of constitutional case-law in this matter clarifies this conclusion.
Against the background of constitutionally permissible compulsory vaccination policies, 134 judgement no. 307/1990 of the Constitutional Court first obliged the legislature to provide no-fault compensation for vaccine injuries. The Court arrived at this conclusion primarily by weighing two aspects of Article 32: the protection of health as a fundamental right of the individual and as a major interest of the community. 135 To guarantee both elements, the legislature was to provide an equitable system of compensation for vaccine-injured individuals. Law no. 210/1992 responded to this and provided the contemporary basis for the vaccination compensation scheme. 136 A right to public compensation was granted to anyone who had suffered permanent impairment of their psycho-physical integrity as a result of vaccinations made compulsory by law or by order of a health authority. 137 The wording of the Act limited the right to compensation to irreversible damages caused by compulsory vaccinations.
Yet the Constitutional Court continued to specify the nature of the relevant obligation. The first step was its holding that the legislature's duty must be viewed in light of Article 2. 138 Hereby, individuals are required to fulfil fundamental duties of political, economic and social solidarity. Individuals receiving a vaccination fulfil a duty of solidarity by acting in the collective interest and for the protection of others, while incurring a risk to themselves. As a result, the community is, in return, bound to the individual by this duty. 139 The right to compensation is thus understood to be based on reciprocal solidarity, and on the consideration that withholding compensation from an individual who has sacrificed themselves for the public good would be contrary to a principle of justice. 140 It would be unfair and unconstitutional to impose a solidarity obligation from which only one side would benefit. 141 Utilising this theory, the Court has expanded the statutory scheme-holding that fair compensation must also be provided in the case of certain recommended vaccinations. 142 As an immediate effect of these judgments, the compensatory scheme was extended to damages from vaccinations that are (only) strongly recommended by the health authorities. The purported distinction between compulsory vaccinations and those 'merely' recommended could not justify a differentiation in the support of those who may be harmed by them. 143 The principle of solidarity operates with the same force in both scenarios. It would be irrational to compensate those who were compelled by law to be vaccinated while denying it to those who voluntarily received it out of considerations of social solidarity and public benefit-which were suggested by the government campaign. 144 The payment scheme was consequently extended without legislative mediation: Law no. 210/1992 remained in force, but specific noncompulsory vaccines could be brought into its scope.
The most recent judgement, no. 118/2020, specified this case law. 145 It emphasised that the compensation regime can only be extended to newly recommended vaccinations upon explicit consideration by the Constitutional Court, which must check for the fulfilment of certain criteria. 146 In particular, it must assess whether the campaign was suited to instil in citizens a sense of duty towards safeguarding public health in the interest of the community and confidence in the recommended vaccine. 147 This clarification was initially applicable to COVID-19. In fact, until the enactment of Decree-law 27th January 2022, no. 4, only people belonging to a category for which vaccination was compulsory (i.e. healthcare workers and, later, individuals over the age of 50) could successfully apply for compensation. For the remainder of the population, a prior submission to the Constitutional Court would have been necessary. However, the intense awareness campaigns launched by the government, as well as the quasi-coercive instruments put in place to fight the pandemic, 148 left the outcome of such a case in little doubt. 149 It is against this background that, in January 2022, the government finally rectified its unconstitutional omission by explicitly extending the scheme to COVID-19 vaccinations.

United States
The National Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP) are the two key no-fault vaccination compensation schemes in the USA. Aiming to balance efficient and fair compensation avenues for those affected by vaccines with vaccine manufacturers' protection from liability, VICP compensates those who experience injury by a covered vaccine, one that the CDC recommends for routine use among children or pregnant women and is subject to a federal excise tax. 150 The Vaccine Injury Table lists eligible vaccinations and enumerates the potential injuries associated with a vaccine's administration, as well as the time period in which such conditions manifest. 151 If a petitioner's symptoms match table conditions, reviewers can presume causal association. For unlisted injuries, the petitioner must prove the vaccine caused the injury. 152 CICP, the second no-fault compensation scheme, is authorised by the Public Readiness and Emergency Preparedness Act (PREP Act). Activated during public health emergencies, CICP compensates for injuries related to countermeasures administered to counteract health security threats, a category under which vaccinations fall. 153 Barring wilful misconduct, the PREP Act grants tort claim immunity under federal and state law for countermeasure manufacturers, distributors, prescribers, administrators, dispensers, or programme planners. 154 CICP petitioners may need to present significant scientific evidence to make their cases for causation, as temporal association alone may be insufficient to prove injury. Only listed injuries create 'rebuttable presumptions' that a countermeasure caused the injury. 155 The origin of federal legislation that gives rise to VICP and CICP can be traced back to focusing events that elevated the need for vaccine-related recourse. In the 1980s, focus heightened on parents' litigation against pharmaceutical companies for their children's alleged adverse health events shortly following diphtheria, pertussis, and tetanus (DPT) vaccination. 156 Simultaneously, Congress heard testimony from a variety of stakeholders on immunisation safety. 157 Manufacturers' hesitation, ignited by uncertainties related to pending legislation, evolving jurisprudence, potential windfall tort awards, and difficulties in acquiring liability insurance resulted in manufacturers leaving the market, and ultimately shortages for certain vaccines. 158 Created through the National Childhood Vaccine Injury Act of 1986, VICP attempts to balance recourse with liability protection against windfall judgements and litigation costs. 159 CICP's origins relate to focusing events involving national security. The PREP Act, was passed in the wake of the September 11 terrorist attacks and the fear of bioterrorism. 160 CICP, a PREP Act component, ensures the supply of medical interventions, like vaccines, in exchange for manufacturer liability protection.
Rather than include COVID-19 vaccines in VICP, pandemic-related vaccination remains extraneous to the traditional system. During public health emergency declarations, like the COVID PREP Act declaration in March 2020, claims for compensation due to adverse vaccination events are routed to CICP. 161 Importantly, CICP petitioners cannot later recover under VICP, even after the emergency. 162 While other PREP Act aspects have been periodically amended during the pandemic, the legislation has not been amended to expand compensation. To date, COVID-related injuries are not listed in statutory Covered Countermeasures Injury Tables. 163 Arguably, access considerations were seeded in political will for the ultimate passage of compensation schemes through congressional legislation. Given the nation's experience with vaccine supply disruption, market availability relied on balancing compensation for harm and liability protection. VICP and CICP solutions provide tort protection incentives for a consistently available vaccine supply, thus enabling access. With litigation mounting and no state duty to ensure vaccination supply, Congress realised the role of vaccines in ensuring health and welfare and acted. VICP motivations allude to an understanding of fairness that gives deference to pharmaceutical manufacturers. Solidarity against a common threat could also be inferred. However, such schemes seem to operate under the assumption that risk and access are distributed evenly among the population. Given the significant body of health equity research, especially in light of COVID-19, that assumption is inadequate.
Despite similarity in nomenclature and no-fault conceptions, VICP and CICP differ in their petition conditions and compensation award. 164 In terms of qualifying injury, CICP covers only serious physical injury and death whereas VICP covers not only deaths, but also injuries with effects lasting for six months or more following vaccine administration, as well as hospitalisation or surgery. 165 CICP is also criticised for being a less generous compensation programme. CICP reimburses for 'reasonable and necessary' medical expenses, as well as some lost employment income. 166 Lost employment income is limited to 66 2 = 3 percent of the injured's unreimbursed gross income at the time of injury, up to $50,000 for lost employment annually until the age of 65 years. 167 Projected future earnings are not considered in the calculation. 168 While some medical expense payments are allowed without limit, 169 there is no compensation for pain and suffering, rehabilitation, special education, or other therapies, among other restrictions. 170 An injury under the VICP scheme, however, awards petitioners actual and projected non-reimbursable expenses for medical care, rehabilitation, residential care, behavioural healthcare, support services and other related expenses without limit. 171 Additionally, VICP can award up to $250,000 for actual and projected pain and suffering and emotional distress, as well as lost earnings and 'reasonable' lawyers' fees and legal costs. 172 CICP does not reimburse for legal fees, whereas relief may be available in qualified VICP cases. 173 CICP's processes, in which applicants have limited opportunities to participate in determinative agency proceedings, are non-transparent. 174 Moreover, CICP proceedings are clandestine, as petitions are privately assessed by department officials, without time limits or interaction between officials and petitioners. 175 Without published CICP decisions, the public is not privy to the evaluation of adverse events linked to a vaccine. 176 VICP, a judicial process, offers judicial avenues for appeal, whereas CICP, an administrative process, offers a one-time administrative reconsideration. 177 Together, these differences indicate that, generally, awards for COVID-related vaccine injury will be less generous, compared to non-emergent schemes, after a lengthy, expensive, and non-transparent administrative process pursuing compensation. 178

IV. NORMATIVE EVALUATIONS OF VACCINATION AS AN EQUALISER
A. Vaccine Prioritisation Each of the three approaches to vaccine prioritisation sought to address health inequities in the distribution of vaccine access. One commonality is that age, correlated comorbidities and healthcare occupation were consistently prioritised in all of them. Further, the three countries all made some provision for the disabled. The precise nature of this category and the urgency of vaccination were not consistent, however. While England and Italy both placed certain disabled individuals relatively high on their national priority lists, the former created a problematic distinction between those who were severely and moderately disabled. The distinct needs-both clinical and social-of those deemed moderately disabled were not initially met. Only after a failed legal challenge and after local actors began to prioritise this group was this changed. Italy's fine-grained approach to eligible disabilities may be similarly critiqued and, it too, had to amend its policy. Hereby it implemented a more comprehensive approach in early March, which could draw on an established statutory definition. The USA did not provide for a consistent national approach at all. The term disability was variably defined in the context of COVID vaccination, leading to inconsistent treatment across state lines. Consequently, the response to this vulnerable group's need was variable, limited and liable to be adjusted.
Such variance is even more pronounced when one looks at the handling of the other socially disadvantaged populations. Across and within the three states no consistent prioritisation approach can be identified. In the USA, national advice encouraged federal and local decision-makers to consider race, ethnicity, and socio-economic status in the allocation of vaccines. In the absence of legal obligations, this was only ever considered in some localities. Some states also went beyond national advice, placing especially vulnerable groups-including the homeless and prisoners-into high priority categories. This highlights the overall heterogeneity of response and of upholding equity as a value. Beneficial local approaches could also be found in England, albeit to a much more limited extent, in the initiative that select local authorities took in the prioritisation of the homeless and which ultimately led to a change in national strategy. By comparison, the local dimension of the Italian scheme was distinctly negative. While the criterion of 'essential activities' had the potential to benefit some vulnerable groups indirectly, this was variably and counterproductively applied and ultimately abolished. The national scheme compared favourably, however, by granting prisoners priority-status early on.
The legal frameworks structuring these categories exerted a varied and limited influence across all nations, despite the importance of the issues at stake. The USA provides a stark example of how the substantive requirements of constitutional law constrained their consideration. The US Supreme Court's precedent of applying strict scrutiny to policies based solely on explicit racial or ethnic distinctions discouraged states from directly incorporating these groups' disparate needs into prioritisation decisions. Though the law did not prohibit the incorporation of more indirect measurements or a direct focus on other particularly vulnerable groups, the patchwork of prioritisation attests that those positive decisions were much more attributable to political will than to legal norms in the USA. The emergence of such a patchwork highlights the fickleness of relying on political norms over procedural or substantive options, which can lead to further social fission along lines of disadvantage.
Italy's substantive constitutional framework had a positive, albeit limited, influence on the implementation of the vaccination plan. Admittedly, the government strategy for prioritisation responded to constitutionally recognised needs. This was reflected in: the prioritisation of those with a higher clinical need for the vaccine, the consideration of wider social determinants of health, and the abolition of the 'essential activities' category, whose implementation was constitutionally suspect. However, the constitutional principle of equity could not provide concrete standards for the extension of the vaccination plan to other disadvantaged groups. Here the Constitution left room for considerable political discretion, especially in light of the initial vaccine scarcity. Beyond implicitly informing the vaccination scheme, Italy's system of substantive rights therefore also ultimately left the pursuit of an equitable response to political actors.
Under the English framework, it was not substantive rights, but legal requirements for a process-driven incorporation of equity considerations that influenced vaccine prioritisation, with decision-makers conducting relevant assessments. Moreover, the legal challenges initiated under this duty contributed to an important body (the JCVI) recognising its relevant obligations and to an amendment of the national prioritisation scheme in favour of individuals with learning disabilities. English law did not allow for successful challenges of specific decisions, but it furthered the realisation of equity objectives in the political sphere.
Overall, there were significant limitations in the ways that each of the prioritisation programmes tackled health inequalities. This was demonstrated not only by the variations and amendments within states, but especially by the different responses to comparable problems across them. Unfortunately, legal frameworks did relatively little to counteract these deficiencies: they did not demand consistent or comprehensive approaches to health inequities. Here there is definite room for improvement.

B. Vaccine Injury Compensation
An equitable vaccination campaign not only involves a fair distribution of vaccines but also requires the encouragement of utilisation and a response to the unequal burdens (vaccine injury-induced disability) that are created from their deployment. The examined compensation schemes purportedly pursue these interrelated goals, and yet it will be argued that the legal frameworks of the Anglo-Saxon countries are ill-suited to this task. In contrast, the Italian scheme, informed by a substantive right of solidarity, requires an equitable redistribution of resources and provides the requisite certainty, comprehensiveness, and consistency to instil public confidence.
For COVID-19 the pursuit of these objectives initially meant that coverage had to be extended to this novel virus. This occurred in all jurisdictions, but in distinct ways. In the USA, coronavirus undoubtedly fell under a bespoke legislative scheme designed for emergencies, providing coverage for potential injuries. Similarly, while Italy only has a single scheme, its constitutional jurisprudence set out clear, forward-looking criteria that provided the requisite reassurance. Even before the extension to COVID-19, this guaranteed that injuries from state-encouraged vaccines would be compensable. By contrast, the English scheme was the most uncertain. Lacking a pre-existing means of extending it to COVID-19, prompt executive action was necessary to pre-empt doubts regarding coverage.
The programmes' wider entitlement conditions speak directly towards the group of vaccine-injured individuals that will receive support for their situation. In all jurisdictions, the removal of a fault requirement ensures that greater coverage is achieved than by the ordinary judicial process. This is complemented by the prospect that the 'easy availability of compensation increases willingness to undergo vaccination'. 179 For this purpose a programme must not only be in place, but it must be seen to cover deserving individuals and it must also be accessible to disadvantaged groups.
The American and English programmes fall short in the realisation of these aims. The procedural hurdles under the US scheme pose distinct problems for accessibility, impacting petitioners who lack access to legal or financial resources. In addition, both jurisdictions impose restrictive entitlement conditions. Most significantly they only compensate for death or serious injury. Needs that may be significantly heightened but fall below this threshold go unmet. As with prioritisation, an arbitrary distinction is created between different kinds of disability and, in both jurisdictions, this is conceptualised as a political decision with little to no legal direction. In particular, the unsuccessful claims under the ECHR illustrate the limited nature of the UK's substantive rights and, in contrast with vaccine prioritisation, its procedural approach has effected little. It did precipitate an extension of the scheme to older age groups and it did lead decision makers to posit a connection between the scheme and confidence in the COVID-19 vaccines. Yet there was no thorough examination of other vulnerable populations, vaccine hesitancy and the potentially positive effects of further relaxations. This was said to be precluded by practical political considerations.
In comparison, the Italian scheme is much broader, flowing from a constitutional obligation of social solidarity. As this obligation applies equally to all vaccine-damaged individuals, the legislation lists even relatively minor forms of damage as compensable harms. Insofar as the schemes are intended to achieve a redistribution based on unequal need, the law has played a remarkably positive role, mandating a truer approximation to this ideal. This framework also means that an individual is assured that if they act in solidarity by participating in the state's vaccination policy they will be supported should they suffer injury as a result.
Causation requirements pose a special problem for schemes that seek to assist the vaccine injured and encourage trust in vaccination. If the causation standard is set too high, it may exclude many deserving individuals, potentially impacting the public's perception of the scheme-especially since causation is notoriously difficult to establish for vaccine injuries. Arguably this is evidenced in England, and to a lesser extent the USA, where restrictive causation requirements noticeably impact the success of claims. 180 If the standard is set too low, however, the success of spurious claims can make vaccine risks appear greater than they are, so that compensation schemes could negatively impact public trust. 181 Italy exposes itself to this danger, given that some courts have eased the relevant requirements. Moreover, the offsetting benefits for public confidence are limited by the fact that this represents a case-law driven approach whose contestability has consequences for transparency and predictability. 182 Nevertheless, this relaxation of causation is influenced by the objectives underlying the Italian compensation scheme, including the realisation of its social support function. To this extent (without evaluating compensatory justice) it represents a preferable model. It creates a space for the law to frame these considerations and prevents an unduly onerous causation requirement from effectively undermining the equityrelated objectives of such schemes.
Permissible access conditions only go so far towards generating public trust or meeting this group's needs. One must also regard the remedy. Here again the Italian model stands out. Multiple generous awards are provided as continuous payments to support the vaccine-injured. Both England and the USA offer more nominal awards, with England being easily the least generous. These sums do not comprehensively or continuously meet individual needs. Awarding immunity from civil law claims to relevant private parties adds another problematic dimension. Whereas the operation of these schemes is usually premised on the 'backstop' of such claims, this has been denied under present circumstances.
Vaccination compensation schemes purport to marry the goals of meeting the injured's needs and encouraging vaccine uptake. Of the three nations, Italy's approach, shaped by its legal framework, is best suited to achieve this aim. The Italian Constitution determined the compensation scheme's creation, its extension to COVID-19, and the provision of adequate remedies. The USA and England compare poorly. Although the U.S. scheme also provided certainty regarding the coverage of COVID-19, both have restrictive access conditions and offer only limited remedies, England in particular. Ultimately, the fact that the Anglo-Saxon schemes are political creations permitted a neglect of equity considerations. It remains an ongoing task to make decision-makers aware of them and to precipitate positive legislative changes.

CONCLUSION
In a pandemic that has highlighted so much socially derived inequity, stakeholders had the opportunity to ameliorate inequities in their COVID-19 vaccination campaigns. These were reasonable means of addressing profound societal challenges and it was seen that England, Italy, and the USA grappled with this task. This article highlighted the role of the law in this pursuit. Even amongst schemes with overlapping objectives, there was not one ideal framework. Where wider legal norms had a limited influence, this admittedly contributed to variable responses and dissonance in the realisation of relevant aims, as is exhibited especially by the U.S. and English schemes. Yet for the vital task of vaccine prioritisation, the latter's light-touch procedural approach was a valuable mechanism that directed political decision-makers towards the implementation of equity considerations. The Italian Constitution, with its strong substantive rights, offered little guidance for this sensitive dimension, while playing a central role in creating a coherent and comprehensive vaccine injury compensation scheme. While basic legal institutions may not be readily transplantable, their respective advantages and drawbacks ought to be recognised. To this end, this article has sought to illustrate what is possible in the pursuit of equitable vaccination campaigns.
Conflict of interest statement. None declared.

FUNDING
The authors did not receive funding for this work.